Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRebecca E Kotcher, MD
About this trial
The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures. The main question it aims to answer is:
\- Does bright blue light therapy in addition to standard pain treatments improve pain with breathing in adults with painful rib fractures?
Researchers will compare participants who receive bright blue light therapy to participants who receive white light therapy and participants who receive only usual lighting conditions to look for differences in their pain control. In addition to their assigned light treatment, all participants will receive standard pain control treatments.
Participants will be assigned randomly to one of three groups: one-third will be assigned to bright blue light therapy, one-third will be assigned to bright white light therapy, and one-third will be assigned to usual light only. They will receive their assigned light treatment for 4 hours during the morning/early afternoon for up to 3 days while they are in the hospital. On each day they receive the light treatment and on the day after their final light treatment:
* They will be asked twice to rate their pain at rest and with taking a deep breath. * They will be tested to confirm that they are not experiencing delirium, or confusion related to being in the hospital. * Blood samples will be collected to look for changes in inflammation and the circadian clock, the body's natural 24-hour cycle.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than or equal to 18 years
Admitted to a single large academic level I trauma center (Presbyterian/Montefiore hospital) within the first 48 hours of traumatic injury
Greater than or equal to 1 acute rib fracture
Pain related to rib fracture(s), by one or more of the following criteria: 1. Pain >/= 4/10 at rest, 2. Pain >/= 4/10 with incentive spirometer (IS) use, and/or 3. Inspiratory volume < 1000 cc
Disqualifiers
Mechanical ventilation* or non-invasive positive pressure ventilation administered for respiratory insufficiency prior to the time of informed consent
Delirium (positive CAM screening) at the time of informed consent
Ocular trauma, which may interfere with the mechanism of action
Traumatic brain injury (TBI) or history of TBI or stroke, which may interfere with the mechanism of action
Trial design
Design model
Parallel
Treatments tested in this trial
Bright Blue Light
DeviceBright blue light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#132, Medium Blue) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Bright Full-Spectrum (White) Light
DeviceBright full-spectrum (white) light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#211 0.9 ND) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Usual Ambient Light
DeviceAcross all arms, the usual ambient light in the inpatient room will not be modified. For the Bright Blue Light and Bright Full-Spectrum (White) Light arms, light will be added to the environment using a Day-Light Classic Plus Light Therapy Lamp as specified in the corresponding intervention descriptions. For the Usual Ambient Light arm, a Day-Light Classic Plus Light Therapy Lamp mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended) will be positioned at a 12-14 inches from eye level with the on/off switch in the off position. The lamp will be positioned in this manner for 4 hours daily during the morning/early afternoon hours, for up to 3 days.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Bright Blue LightExperimental treatment 2 interventions
Group B: Bright Full-Spectrum (White) LightActive comparator 2 interventions
Group C: Usual Ambient LightOther 1 intervention
Trial outcomes
Primary outcomes
1
Chest wall pain intensity, with incentive spirometer use
Chest wall pain intensity with deep breathing will be measured using the Numerical Rating Scale, elicited when the participant is taking a full tidal volume breath using their incentive spirometer. The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The scale will then be assessed at multiple timepoints during the 72 hour period of active study participation including twice daily on up to three intervention days (study days 1-3) and once on the morning following the final intervention day (study day 4 or day of discharge). Pain scale values over time will be compared across study arms.
Time frame
Up to 72 hours (assessed twice daily)Secondary outcomes
1
Intensive care unit-free days
Intensive care unit-free days at 30 days is calculated as 30 minus the number of days spent in an intensive care unit. Participants with death occurring within 30 days of enrollment will be assigned 0 ICU-free days. This will be assessed at 30 days using chart review and, for patients discharged from the hospital, confirmed during a single follow-up phone call. Thus, the range for each participant will be from 0 to 30 days. Differences in ICU-free days will be compared across study arms.
Time frame
30 days2
Rev-Erb alpha expression
Rev-Erb alpha is a circadian clock protein that will be used as a surrogate for circadian clock activation. Rev-Erb alpha expression will be quantified using Western Blot on blood samples collected each morning for up to 4 collections over the course of active study participation. Rev-erb alpha expression over time will be compared across study arms.
Time frame
Up to 72 hours (blood samples collected daily)3
IL-6 concentration
Pro-inflammatory cytokine IL-6 concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. IL-6 concentration over time will be compared across study arms.
Time frame
Up to 72 hours (blood samples collected daily)4
TNF-alpha concentration
Pro-inflammatory cytokine TNF-alpha concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. TNF-alpha concentration over time will be compared across study arms.
Time frame
Up to 72 hours (blood samples collected daily)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rebecca E Kotcher, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institutes of Health (NIH)
Collaborator
National Institute of General Medical Sciences (NIGMS)
Collaborator
Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh
Collaborator
Clinical and Translational Science Institute (CTSI), University of Pittsburgh
Collaborator
Source ClinicalTrials.gov